Nipple cover

ABSTRACT

One aspect of the present application relates to a covering member for a protruding portion of a patient&#39;s body. This cover is flexible and collapsible so that it conforms to the shape of the encased portion of the body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/083,442, filed Apr. 8, 2011, which is a continuation of U.S. patentapplication Ser. No. 12/368,257, filed Feb. 9, 2009, now U.S. Pat. No.7,921,851 which is a continuation of U.S. patent application Ser. No.11/291,738, filed Dec. 1, 2005, now U.S. Pat. No. 7,487,779, which is acontinuation of U.S. patent application Ser. No. 09/793,110, filed Feb.27, 2001, now abandoned, all of which are hereby incorporated byreference herein in their entireties.

BACKGROUND

1. Field of the Inventions

The present invention relates to a device for covering and applying amedicament to a protruding portion of a mammalian body. Morespecifically, the present invention relates to a flexible, continuouscovering apparatus that surrounds the protruding body portion in orderto protect it and/or retain a medical agent on it before or after anoperation or other medical procedure has been performed.

2. Description of the Related Art

Certain medical procedures require that an agent, such as a medicament,be topically applied to, and maintained on, a portion of a patient'sbody. The need for the agent can arise before or after the medicalprocedures have been performed. These procedures can comprise patientexaminations, minimally invasive diagnostic operations, exploratoryoperations and invasive therapeutic operations. The patient examinationsmay include the step of positioning a medical device, such as a probe,scope or catheter, within a body passageway to perform an examination orretrieve material from within the passageway or a related body cavity,such as a duct.

Topical anesthetics are an example of one class of medicaments that maybe applied to the portion of the body hours before and/or after theintended procedure is performed. For example, topical anesthetics canprepare the body portion to receive a medical device that will bepositioned within a body opening or incision during the procedure. Acomposition including an anesthetic and another active agent may also beused. In the situation where the composition is applied to a breast toprepare it for ductal access, a dekeratinizing agent and/or a ductalorifice dilating agent such as capsicum may be used. Agents applied postprocedure might include topical antibiotics or well-known wound healingagents.

When the anesthetic is applied before the procedure, a cover, such as abandage, is normally positioned over the anesthetic to prevent it frombeing prematurely wiped off. However, conventional covers do not offerthe patient an effective option for covering the anesthetic for an houror any other extended period of time that is sufficient to prepare(numb) the body portion. Instead, these covers lay like a flat drape,are normally ineffective and are uncomfortable to wear, especially whenthe patient is active between the time the anesthetic is applied and theprocedure is performed. Hence, the patient may only wear the cover andthe anesthetic for a short time before the procedure begins.Unfortunately, when this occurs, the amount of discomfort experienced bythe patient during the procedure may be significantly increased.

Alternatively, the bandages can be wrapped circumferentially around theportion of the body being treated like an open ended cylinder if thetreated portion is part or all of a protruding body member. However,these bandages do not cover, encapsulate and isolate the portion of thebody from its normal environment. Examples of the protruding bodyportions that do not form effective seals with conventional bandagesinclude, but are not limited to, nipples, fingers, toes, noses andpediatric penises.

When either of the conventional bandages is used on one of theseprotruding body portions, they cannot effectively cover and enclose theapplied agent so that it does not leak out. Instead, the appliedmedicament may leak out from under the bandage and onto other parts ofthe patient including her clothing. This can result in less than apreferred amount of the agent remaining on the protruding body portionfor the prescribed period of time. If enough leaks out from under thebandage, the overall effectiveness of the agent will be significantlyreduced and the procedure may have to be postponed. If the procedure isnot postponed, as discussed above, the patient may experience anunnecessary amount of pain and discomfort. When either circumstanceoccurs, the patient and the healthcare facility can become frustrated.If excessive amounts of the agent are applied in anticipation of some ofit leaking out from under the bandage, the added amount may adverselyeffect the adhesive portion of the bandage and prevent any portion of itfrom adhering to the patient. If this occurs, the amount of the agentthat will leak out from under the bandage will be excessive.

Other problems may also occur with the use of flat bandages. Forexample, it could be very embarrassing if the applied agent leaks outfrom under the bandage and stains the patient's shirt, pants, etc. Theembarrassment may be enhanced depending on the location of the stain.Additionally, the cost of cleaning or replacing the garment that hasbeen stained can be significant. These additional costs may frustratethe patient and possibly discourage her from having the same procedureor examination performed again. Moreover, problems and embarrassment canresult if the stains cause other people to question their origin andlearn about the procedure that the patient is about to undergo.

Covers for specific protruding body portions are well known. One suchtype of cover includes nipple covers for lactating nipples that permitexpelled fluid to dry on the nipple. Examples of these covers aredisclosed in U.S. Pat. No. 3,840,012 to Rushton, Jr., U.S. Pat. No.5,032,103 to Larsson and French Patent No. 792,353 to Proquitte et al.These nipple covers include openings along their outer surface thatpermit air to enter the interior of the cover and dry any fluid expelledfrom the breast. As a result, these covers cannot be used to hold amedicament on a nipple. If they were, the medicament would leak outthrough the air hole(s) and onto the clothes of the patient. Therefore,the use of these covers would be pointless.

Other types of devices without ventilation holes are also used to covernipples. One such nipple cover is used to cover the nipples of male longdistance runners. Such a cover is disclosed in U.S. Pat. No. 5,743,272to Kocher, Jr. Unlike the above-discussed covers for lactating nipples,the male nipple covers do not include ventilation openings. Instead,these covers have large, flat outer end surfaces. Additionally, thesecovers are not laterally or longitudinally flexible. As a result, theydo not collapse around the nipple and conform to its shape. Therefore,others will readily notice these nipple covers when worm. This is notacceptable for women who need to wear a medicament containing nipplecover under their clothing during work or other activities in order toprepare their nipples for an examination or procedure such as ductallavage. These nipple covers will be conspicuous and possibly embarrassthe person using them because they can be easily seen under clothingwhen worn.

SUMMARY

One aspect of the present invention relates to a covering member for aprotruding portion of a patient's body. This cover is flexible andcollapsible so that it conforms to the shape of the encased portion ofthe body. This prevents the cover from being noticed while it is wornunder clothing. The cover can contain a medicament or agent for treatinga portion of the body before and/or after an examination or procedure.When the cover is used to apply a topical anesthetic to a portion of thebody for a recommended period of time prior to the procedure orexamination commencing, the amount of discomfort experienced by thepatient can be significantly reduced compared to the amount experiencedby the patient who has the anesthetic applied for just a few momentsbefore the procedure begins. Alternatively, the cover can be used tohold a medicament or agent on the intended portion of the body in orderto heal a wound or cure a condition such as a skin rash or the like.

One embodiment includes a cover for a protruding portion of a mammalianbody. This cover comprises first and second flexible members. The firstmember includes a securing portion, at least one sidewall and at leastone end wall. The sidewall and end wall form a continuous, uninterruptedwell for receiving and covering the protruding body portion. The secondflexible member has a first surface for attaching to the securingportion of the first member and a second surface for securing to thebody so that the second surface does not move relative to the body.

Another embodiment includes a flexible nipple covering apparatus forenclosing a mammalian nipple. The covering apparatus comprises ananchoring member for securing to a portion of a body carrying thenipple. The cover also includes an uninterrupted nipple receiving wellthat has at least one sidewall and at least one end wall. The well issecured to the anchoring member in order to form a sealed enclosureabout the nipple when the anchoring member is fixed to the body. As aresult, the anchoring member and body are free of relative movement.

A further embodiment includes a flexible apparatus for covering andisolating a nipple of a mammalian body. The apparatus comprises a basefor positioning proximate an areola and an internal well for receivingthe nipple. The well includes at least one sidewall and at least one endwall at an opposite end of the apparatus from the base. The well, thebase and the end wall form a continuous, uninterrupted nipple enclosurefor holding an agent on the nipple.

The present invention also includes a method of preparing a portion of abody for a medical procedure. The method includes the steps ofpositioning a flexible covering apparatus including a well and ananchoring member over the body portion and locating the body portion sothat it extends within the well. The method also includes the steps offixing the covering apparatus to the body around the covered bodyportion so that a seal is formed between the anchoring member and thebody and applying an agent to the body portion.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of a cover for a protruding body portionaccording to the present invention;

FIG. 2 is a top view of the cover illustrated in FIG. 1;

FIG. 3 is an exploded perspective view of the cover;

FIG. 4 is schematic view of the cover illustrated in FIG. 1 secured overa nipple;

FIG. 5 illustrates the cross section of an alternative embodiment of thecover according to the present invention; and

FIG. 6 illustrates the cross section of a third embodiment of the coveraccording to the present invention.

DETAILED DESCRIPTION

The present invention relates to a flexible cover 10 for enclosing aprotruding body portion and effectively isolating the body portion fromits surrounding environment as shown in FIG. 1. The cover 10 can beapplied to the body before or after a medical procedure is performed. Inone embodiment, the cover 10 is applied prior to a procedure beingconducted in order to prepare the body portion 1 for the procedure. Inanother embodiment, the cover 10 can be used to enclose a protrudingportion of the body 1 after a procedure has been performed in order toisolate the body portion 1 and prevent infection. With eitherembodiment, the cover 10 can hold a desired amount of an effectivetopical agent 100 on the body portion 1 and prevent the agent 100 fromleaking to other parts of the patient's body or his/her clothes. Thecover 10 can be repeatedly used as an applicator for initial orsupplemental amounts of the agent 100. Alternatively, the cover 10 canbe disposed after the first application of the agent 100.

The agent 100 can be any type of topical agent used on the body. Forexample, the agent 100 can be, but is not limited to, a topicalanesthetic capable of anesthetizing a region of a patient's body portionin preparation for a diagnostic examination or another medicalprocedure. Additionally, the agent discussed herein could include any ofthe agents disclosed and defined in U.S. Provisional Patent applicationNo. 60/252,090 to Hung and Patel, which was filed on Nov. 21, 2000 andentitled “Preparation for Breast Duct Fluid Collection.” Thisprovisional application is hereby fully incorporated by reference.Additional agents that are customarily used on the body after anoperation can also be retained and/or applied on the body portion 1 bythe cover 10.

As used herein, the term procedure can include any of the medicalprocedures discussed above or any additional procedures that are knownto medical practitioners. For ease of explanation, the cover 10 will bedescribed as it is used to prepare a breast nipple for a diagnosticexamination such as ductal lavage. Ductal lavage includes theintroduction of a fluid into a mammalian breast duct and the retrievalof a composition from within the duct via a lumen that extends throughthe nipple and into the duct. U.S. patent application Ser. No.09/473,510 to Hung et al., which is hereby incorporated by reference,provides a more detailed description of ductal lavage. While, thepresent invention is being described with respect to ductal lavage, itsuse is not limited to this procedure. For example, as discussed above,it may be used to cover and retain a medicament on other portions of abody including a pediatric penis and a nose. The cover 10 can also beapplied over one or more fingers or toes.

FIG. 1 illustrates a first embodiment of the cover 10 for positioningover a protruding body portion. While this embodiment of the cover 10and the others disclosed below can be used to cover many different bodyparts, such as those discussed above, for clarity, the cover 10 willonly be discussed as it is used to cover a nipple 110, shown in FIG. 4,in order to prepare the nipple 110 for a medical procedure. Thepreparation includes the steps of (1) applying an anesthetizing agent tothe nipple 110, (2) positioning the cover 10 over the nipple 110 and (3)forming a seal between the cover 10 and the patient's body. The formedseal prevents the agent from leaking out of the cover 10 and onto otherparts of the patient, including her clothes. According to the presentinvention, the agent can be applied directly to the nipple 110, appliedonly within the cover 10 or a combination of both. The cover 10 thenencloses the nipple 110 for a predetermined period of time that issufficient to prepare it for the intended procedure. The cover 10 andagent can be securely positioned over the nipple 110 for about twominutes to about forty-eight hours prior to the procedure. In apreferred embodiment, the cover 10 and agent are securely positionedover the nipple 110 for about one hour to about ten hours prior to theprocedure. In another preferred embodiment, the cover 10 and agent aresecurely positioned over the nipple for about two hours to about fourhours prior to the procedure.

The cover 10 is a unitary, continuous uninterrupted enclosure thatisolates the nipple 110 from its surrounding environment. As shown inFIG. 1, the cover 10 includes a body portion covering chimney 20 and abase 30 that is secured to the patient after the cover 10 has beenpositioned over the nipple so that a seal is formed between the patientand the cover 10. As used herein, the term “chimney” refers to anelongated portion of the cover 10 that includes an internal receivingwell and that extends longitudinally away from the base 30 in the samedirection that the nipple 110 protrudes from the body. The shape andsize of the chimney 20 and the base 30 will depend on the portion of thebody they are intended to cover. For example, the cover 10 for a nipplemay have different dimensions than a cover 10 for a toe.

As shown in FIG. 3, the chimney 20 includes an agent and a nipplereceiving well 21. The chimney 20 also includes portion that forms asecuring ring 28 having a lower surface 29 for attaching to the base 30as discussed below. The well 21 is defined by at least one sidewall 22and a distal end wall 23. The number of sidewalls 22 will vary with theshape of the well 21. For example, a well 21 that has a circular,substantially circular or elliptical cross section may have only onesidewall 22. However, a well 21 with a triangular, square, rectangular,diamond, or other known polygonal cross section will include more thanone sidewall 22 as shown in FIGS. 5 and 6. The distal end wall 23 formsa continuous barrier at one end of the sidewalls 22 of the well 21. Thesecuring ring 28 and end wall 23 are integrally formed with thesidewall(s) 22 so that the sidewall(s) 22, end wall 23 and securing ring28 form a continuous, uninterrupted, flexible enclosure around thenipple 110. In a preferred embodiment, sidewall(s), end wall 23 andsecuring ring 28 are formed from the same piece of material.Alternatively, they can be formed of separate pieces of material andsecured together. Well known securing techniques such as RF welding canbe used. The end wall 23 can be flat, rounded or stepped in between theouter edge(s) 26 of the sidewall(s) 22.

In an embodiment, the sidewall(s) 22, end wall 23 and securing ring 28are formed of a flexible, easily manipulated material that can bestretched into any desired shape. The material is preferablybiocompatible and hypoallergenic. The material can also be resilient. Aresilient material will permit the cover 10 to stretch and conform tothe shape of the nipple 110. In another embodiment, the material holdsits shape after it experiences elastic deformation. For example, in oneembodiment, the flexible, easily manipulated material includes a linearlow density polyethylene (LLDPE). Other known flexible, stretchableand/or elastic materials may be used to form the chimney 20. Examples ofthese well-known materials include, but are not limited to, other typesof polyethylene, plastics, thermoset polymers, thermoforming polymers,paper, TYVEK®, webbed materials, composites, and polyesters.

In an embodiment, the flexible material used for at least thesidewall(s) 22 and the end wall 23 is partially transparent so that thenipple 110 can be seen through the cover 10. In another embodiment, thematerial is completely transparent so that the patient, attendant and/orphysician can easily view the nipple 110 and determine the extent of itspreparation or healing without having to remove the cover 10. Thetransparent aspect of the material permits someone to determine ifadditional amounts of the agent need to be applied to the nipple 110without having to break the seal between the base 30 and the patient.The securing ring 28 does not need to be formed of a transparentmaterial. However, if it is formed from the same sheet of material asthe transparent chimney 20 than it may be transparent. Alternatively,the securing ring 28 may also be transparent if the base 30 is at leastpartially transparent. In this alternative embodiment, the cover 10could be easily and accurately positioned on a particular portion of thebody.

The chimney 20 is easily deformable (elastic) under pressure. As aresult, it will collapse around and substantially conform to the shapeof the nipple 110 as the cover 10 is being applied to the body.Typically, the patient or attendant applying the cover 10 will applypressure to the chimney 20 as the cover 10 is applied so that air isexpelled from the well 21 and the sidewall(s) 22 and end wall 23 conformto the shape of the nipple 110. Since the chimney is able to collapseand substantially conform to the shape of the nipple 110, the cover 10will not be visible when it is worn under a patient's clothing. This isespecially important for a woman who may feel self conscious anduncomfortable when a strange shape protrudes from underneath her blouse.The cover 10 illustrated in the figures allows a patient to discreetlywear a cover 10 over her nipple 110. This can encourage the use of thecover 10 in the future. Additionally, as the chimney 20 collapses, anyagent within the well 21 will be forced into contact with the nipple110.

As shown in FIG. 1, the portion of the chimney 20 that forms thesecuring ring 28 is secured to an upper surface of the base 30 byadhesives. In another embodiment, the securing ring 28 has a cohesive onits lower surface 29. The cohesive cooperates with a cohesive carried bythe upper surface of the base 30 that is already secured onto the areolaor another portion of the body surrounding the nipple 110. The use ofcohesives permits easy removal of the chimney 20. The cohesives alsoallow for the chimney 20 to be repeatedly removed without the patientfeeling any uncomfortable tugs on her areola. Additionally, thecohesives will not stick to the person removing or replacing the chimney20 when the base 30 is left on the patient for an extended period oftime.

The base 30 includes a main body ring 31 that makes the cover 10 easy tohandle and position over the protruding nipple 110. The ring 31 extendsin a direction away from the body (thickness) between about 0.0156 inchand 0.25 inch. In one embodiment, the ring has a thickness of about0.0625 inch. In another embodiment, the ring 31 is about 0.03125 inchthick.

In one embodiment, the ring 31 is formed of biocompatible,hypoallergenic cross-linked polyethylene foam that is available fromScapa Medical® having a tensile strength of at least about 160 psi andan elongation of at least about 290%. Other materials that can be usedfor ring 31 include, but are not limited to, other polyethylene foams,polyesters, papers, polyethylene liners, plastics and polypropylenes.

The ring 31 is semi-rigid. It is stiff enough that a person can firmlyhold onto it an easily manipulate the cover 10 without adhesive carryingportions of the cover 10 becoming secured to each other. The ring 31 canbe stiff enough to permit one-handed application of the cover 10. Yet,the ring 31 is flexible enough to conform to the shape of the person'sbody that surrounds the nipple 110. The ring 31 is defined by an outeredge 32 and an inner edge 33. As shown in FIG. 4, the inner edge 33extends around the base of the nipple 110 when the base 30 is secured tothe patient as discussed below. The inner edge 33 defines an opening 35that forms a nipple receiving entrance to the well 21. When the cover 10is positioned on the patient, the nipple 110 will be received in theopening 35 and extend into the well 21.

The base 30 is shown as being circular in shape for ease of explanation.However, the base 30 can have any shape that permits it to securely holdan agent carrying chimney 20 over the nipple 110. Also, while theopening 35 is shown to match the shape of the opening to the well 21,the opening 35 can have any shape that cooperates with one of the abovelisted cross sections of the chimney 20 to receive the nipple 110.Additionally, the shape of the outer edge 32 of the base 30 does notneed to match the shape of the inner edge 33. Instead, as mentionedabove, the outer edge 32 can have any shape that permits the cover 10 tobe securely positioned on the patient and over the nipple 110.

The ring 31 also has a lower surface 36 for contacting and being securedto the patient's body. When the cover 10 is positioned over the nipple110, the lower surface 36 is sized so that it covers a portion of theepidermis and/or the areola around the nipple 110. An adhesive or otherwell-known securing element covers the lower surface 36 so that is canbe securely positioned on the patient. The adhesive can be any known,medically approved skin adhesive, such as those approved by 3M®. In oneembodiment, the adhesive is a synthetic rubber based medical approvedskin adhesive (I-832) available with the ring 31 from Scapa Medical®.When an adhesive is used on the lower surface 36, a removable releasesheet 75 extends over the lower surface 36 to prevent the cover 10 fromerroneously adhering to the body portion. In one embodiment, the releasesheet 75 includes a polyethylene coated paper having a silicone releasecoating on one side.

The adhesive can secure the lower surface 36 to the patient's body foreither a short or an extended period of time. The surface 36 can besecured to the patient for between about two minutes and aboutforty-eight hours prior to (and/or after) the procedure. In oneembodiment, the surface 36 is secured to the patient for about one hourto about ten hours. In another embodiment, the surface is secured to thepatient for about two hours to about four hours.

In one embodiment, the chimney 20 is removed and the ring 31 stayssecured on the patient throughout the procedure. In this embodiment, thering 31 acts as a location to place or affix other items such as tubesand/or tethers etc. The adhered ring 31 may remain or be replaced with apost procedure cover 10, for example containing an antibiotic and/or awound healer, etc.

As can be clearly understood, during the application of the cover 10,the release sheet 75 is removed immediately before the cover 10 isapplied over the nipple 110 and secured to the body. Alternatively, therelease sheet 75 could include two separate pieces. In this embodiment,one piece is removed after the cover 10 has been positioned over thenipple 110. Then, the exposed adhesive can be applied against the bodyso that a partial seal is formed between the cover and the body. Next,the second release sheet will be removed and the base 30 pressed againstthe body. This will close the seal between the body and the cover 10.The seal will prevent any of an applied agent from leaking out of thecover.

In an alternative embodiment, the lower surface 36 can be free of anadhesive. If the lower surface 36 does not include an adhesive, stripsof adhesive carrying tape could be extended across the base 30 to securethe cover 10 to the patient. In another embodiment, the cover 10 couldhave a cohesive on the lower surface 36 that will cooperate with acohesive carried by an outer surface of a ring that is already securedonto the areola or another portion of the body surrounding the nipple110. The use of cohesives allows the cover 10 to be positioned on thebody without the chance of the lower surface 36 becoming erroneouslysecured to the attendant applying the cover 10 or on another portion ofthe patient's body. Additionally, the cohesives permit the cover 10 tobe removed without the patient feeling the discomfort of having anadhesively secured cover being ripped off their sensitive areola. Inthis alternative embodiment, the body contacting ring is secured to thepatient using an adhesive or other well-known securing arrangement.

No matter the manner in which the cover 10 is secured to the patient'sbody, the lower surface 36 must have enough surface area that it formsan effective seal with the patient's body. The seal must be strongenough to prevent the cover 10 from separating from the body. The sizeof the lower surface 36 will vary depending on a number of factors.These factors include at least the following: the length of the chimney21, the amount of pressure that will be normally applied to the chimney21 in order to form it to the shape of the nipple 110 and the weight ofthe amount of the agent that will be applied to the patient and carriedby the cover 10 when the chimney is filled with the agent. The surfacearea of the lower surface 36 is larger for the covers 10 having longerchimneys 21 and/or the covers 10 having large wells 21 intended to carrylarge amounts of the agent. No matter the length of the well 21, thelower surface 36 must have enough surface area that it forms aneffective seal with the patient's body. The seal must be strong enoughto prevent the cover 10 from separating from the body.

As seen in the figures, the chimney 20 has a length L of about 0.001inch to about 3.0 inches. In one embodiment, the length L is about 0.25inch to about 2.0 inches. In another embodiment, the preferred length Lis about 0.63 inch. The diameter D of the base 30 and securing ring 28is about 0.5 inch to about 3.0 inches. In one embodiment, a preferreddiameter D is about 2.0 inches. The diameter I of the opening 35 isabout 0.25 inch to about 2.5 inches, with a preferred diameter beingabout 1.0 inch. The diameter O of the well 21 at the securing ring isabout 0.5 inch to about 2.0 inches. A preferred diameter O is about 1.0inch. The diameter of the end wall 23 can be the same as diameter O orit can be slightly smaller so that the chimney 20 has a tapered profile.The term diameter can refer to corresponding widths for thoseembodiments that do not have circular cross sections.

The above-discussed dimensions are exemplary. Each dimension of thecover 10 can be individually set to match the size of the patient'snipple. For example, it is possible to make the diameter O slightlysmaller than the diameter of the patient's nipple 110 so that thechimney forms a secure fit with the base of the nipple 110. The diameterof the opening 35 does not need to be a function of the length of thechimney 20. Instead, the size of the opening 35 is chosen based on thediameter of the nipple 110 that it will cover.

The cover 10 can be manufactured using any known method for forming awell in a sheet of flexible material. One method of forming the cover 10according to the present invention includes the stop of cold working thematerial until the well 21 is formed. The step of cold working thematerial includes advancing a blunt object, such as a flat or roundedhead punch, into the material until a well having sufficient depth tocover the nipple 110 and hold the agent is achieved. Another known wayof forming the cover 10 includes thermoforming it using the methodcurrently used to form bubble wrap. Additional forming methods includeinjection molding, compression molding and transfer molding.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it will be readily apparent to those of ordinary skill inthe art in light of the teachings of this invention that certain changesand modifications may be made thereto without departing from the spiritor scope of the appended claims.

What is claimed is:
 1. A nipple cover configured to collect fluidsoriginating from a breast duct, comprising: a base configured to anchorthe nipple cover to a portion of the breast surrounding the nipple; anipple receiving well extending from the base, said nipple receivingwell comprising a distal end wall and at least one sidewall; and anadhesive located along a lower surface of the base, said adhesiveconfigured to removably secure the nipple cover to the breast, whereinsaid adhesive comprises a medically approved skin adhesive; wherein thebase and the nipple receiving well form an enclosure that is configuredto receive the nipple and isolate the nipple from the surroundingenvironment when the nipple cover is positioned on the breast; whereinthe nipple receiving well is configured to substantially conform to ashape of the nipple such that at least a portion of each of the distalend wall and the at least one sidewall of said nipple receiving well isconfigured to at least partially contact the nipple when the nipplecover is secured to the breast; wherein the nipple cover comprises apolymeric material that is generally flexible and resilient, saidpolymeric material being biocompatible and hypoallergenic; and whereinthe nipple cover creates a seal with the breast such that ductal fluidssecreted by the nipple are maintained within an interior of the nipplecover while the nipple cover is secured to the breast.
 2. The nipplecover of claim 1, wherein the at least one sidewall comprises a lengthbetween about 0.0001 and 3 inches.
 3. The nipple cover of claim 1,wherein the at least one sidewall comprises a length between about 0.5to 3.0 inches.
 4. The nipple cover of claim 1, wherein the enclosurecomprises a generally circular or elliptical cross-sectional shape. 5.The nipple cover of claim 1, wherein the nipple receiving well isconfigured to retain fluids originating from a breast duct.
 6. Thenipple cover of claim 1, wherein at least one of the base and the nipplereceiving well are at least partially flexible.